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Premarket Tobacco Product Application (PMTA)

Building Regulatory Confidence in Next Generation Nicotine Delivery Products (NGPs) 

Helping create your corporate and product narrative through scientific data and insights to illustrate that your NGP is Appropriate for the Protection of the Public Health (APPH) and contributes to tobacco harm reduction.

Click here to learn about our full-service PMTA Package

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What is a PMTA? 

A Premarket Tobacco Product Application (PMTA) is the regulatory pathway offered by the U.S. Food and Drug Administration (FDA) to market tobacco products in the U.S. Under U.S. law, any product that contains tobacco, tobacco-derived, or synthetic nicotine materials is considered a “tobacco product” and requires a PMTA Marketing Granted Order to be sold in the U.S.
 
The PMTA requires the compilation of significant amounts of data about the proposed product, ranging from the component parts, manufacturing, and supply chain controls, as well as pre-clinical, clinical, and behavioral data. All this information needs to be compiled into a dossier which is then submitted to FDA's tobacco department, the Center for Tobacco Products (CTP), for their review and consideration.

Our Full-Service PMTA Testing and Consultancy Package

Compiling a PMTA dossier requires extensive expertise in the PMTA process and across multidisciplinary scientific areas such as toxicology, physiology, chemistry, biochemistry, environmental assessment, and psychology. Our scientific and regulatory consultants have years of nicotine industry experience and have worked on several successful PMTA applications. We offer a fully integrated PMTA service that includes analytical testing, integrated with scientific strategy, technical writing, troubleshooting, and analysis supported by the extensive regulatory experience of working with the U.S. Food and Drug Administration (FDA).

Scientific Strategy Definition

A strategy definition session will map the best approach for obtaining a Marketing Order for your nicotine or tobacco product. This will consider your company’s strategic objectives, product roadmap, and the data required to meet the PMTA submission threshold. From the definition phase, we will define the overall scientific strategy for your PMTA project. We’ll also discuss bridging strategies from previous submissions or consider future submissions to ensure the program gives you the most efficient plan for delivering your longer-term business objectives.

 

The strategy definition phase is essential for setting your PMTA regulatory project up for success. Having the right scientific strategy will help save time and costs, plus decrease the risk of receiving FDA deficiencies or Refuse to File notifications.

FDA Engagement and Authorized Representation

We advise any manufacturer considering a PMTA to engage directly with the FDA before submission. A Broughton senior regulatory consultant can act as your Authorized Representative and work on your behalf to prepare scientific briefing documents, manage communications or conduct meetings with FDA, and help you understand the nuances of the interactions with the agency.

 

Our consultants have years of experience working with FDA and will ensure your PMTA project is professionally managed throughout. They will be available to lead all contact with FDA and ensure prompt and appropriate communications.

Dossier Compiling and Submission

A PMTA submission requires a substantive dossier to be submitted to FDA. Compiling a dossier requires extensive expertise in the PMTA process and multidisciplinary scientific areas such as toxicology, physiology, chemistry, biochemistry, environmental assessment, and psychology.

 

Our regulatory consultants have deep experience compiling PMTA dossiers and have worked on several projects that received Marketing Orders. They are experienced in using the eTTD format, which reduces time and costs when making amends or future submissions to FDA. Having worked on several successful PMTAs, our scientific and regulatory consultants understand where the threshold has been set by FDA for providing sufficient evidence of Appropriateness for the Protection of Public Health (APPH).

Human Health Studies

Scientific data from Human Health Studies (HHS) are required to substantiate a PMTA. Our full-service PMTA package includes analytical testing in our UK-based GxP accredited laboratories integrated with expert scientific analysis and regulatory consultancy support. Our team has delivered several successful PMTAs for clients and has extensive nicotine industry experience.

 

Our full-service PMTA service includes:

 

Deficiency Letter Support

Following the submission of a PMTA dossier, FDA may issue a ‘Deficiency Letter’ to request additional information or clarification on the data submitted. Deficiency letters are most often received in the Filing Phase of the PMTA evaluation process. They must be responded to promptly to ensure that FDA does not Refuse to File the application.

 

Deficiencies may require further scientific data to be submitted within the predefined time frame of 90 days. Our scientific and regulatory experts have extensive experience in responding to deficiency letters. They can offer insightful strategic advice on bridging data gaps or conducting additional studies to ensure an application meets FDA requirements.

Tobacco Product Master File (TPMF) Updates

The TPMF platform enables raw material manufacturers to share confidential and commercially sensitive information directly with the FDA without sharing it with the manufacturer submitting the PMTA. The TPMF is similar to the Drug Master File for the pharmaceutical industry.

 

Our regulatory experts are experienced in updating and maintaining the TPMF for PMTA clients and can remove this task from your in-house team.

Product Due Diligence and Post Market Compliance

A manufacturer has a duty of care to ensure all the products they sell are compliant with regulations and safe for consumers. The PMTA regulatory framework recommends that once a Marketing Order has been granted, the manufacturer instigates a program to ensure their product's ongoing stewardship and can evidence its continued Appropriateness for the Protection of Public Health (APPH).

 

Our scientific and regulatory consultants can advise on effective due diligence programs to create a robust post market compliance strategy, including ongoing quality control and stability testing in our in-house laboratories. They will also support the collation and reporting of data to FDA.

 

You can read more information on post market compliance services. 

Project Management

A senior scientific consultant with many years of nicotine-related experience will be appointed as a Technical Project Lead, ensuring open communication with your in-house experts to create a common purpose and high-quality outcomes.

 

The Technical Project Lead will be supported by an experienced Project Manager who will coordinate across your PMTA project, ensuring timely communication, accurate meeting notes, and the project remains on track and within budget.

PMTA Submission Modules

Module 1: General Administration

Module 2: Summaries

Module 3: Product Description and Manufacturing

Module 4: Non-clinical

Module 5: Non-clinical individual health

Module 6: Clinical Population Health

Module 7: Environmental Assessment

PMTA Submission

Module 1: General Administration

  • Regional administrative information
  • Not part of the Common Technical Document (CTD)

 

PMTA

 

Download our PMTA Guide for NGP Businesses and learn more about how our scientific and regulatory experts can help you gain marketing authorization for your next generation nicotine product in the U.S. market.

Download the PMTA Guide

What NGPs Require a PMTA in the U.S.

NGPs that fall into the following categories must have been granted a PMTA Marketing Granting Order to be sold in the U.S.

  • Vapes, e-liquids, and e-cigarettes (devices or device/liquid combinations)
  • Heated tobacco products (devices and consumables)
  • Modern oral nicotine pouches

Product Modifications and Reformulations

Even if you already have a product on sale in the U.S. market that has a PMTA Marketing Granted Order, any changes to that product, such as device upgrades and e-liquid reformulations, may be considered as a new product by FDA and therefore require a new PMTA to be compiled and submitted.

generic pod system vape device with 3 pods

PMTA Review Process and Deficiency Letters

There are three phases of FDA review when the PMTA application is submitted.


1. Acceptance Phase
This is an acceptance that the product is a tobacco product and should be reviewed under the PMTA regulatory pathway.


2. Filing Phase
This is verification that the required components of the PMTA are present and the data supplied is adequate for a reviewer to be assigned and the Scientific Review Phase to begin. 


3. Scientific Review Phase
An in-depth FDA review of the dossier modules by an FDA-assigned reviewer.

A deficiency letter will be issued if FDA decides that essential data is missing or the data supplied is insufficient to meet their benchmark for illustrating a product is Appropriate for the Protection of the Public Health (APPH). A deficiency letter is generally received in the Filing Phase of the review process.

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Speak to a scientific regulatory consultant about your next generation nicotine delivery product and learn how we can help ensure regulatory authorization and compliance.



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Nicotine Consultancy Services Resources 

Learn more about how we can help bring your nicotine delivery product to market through our scientific and regulatory consultancy services.

PMTA-Guide-For-NGP-businesses

PMTA Guide For NGP businesses

At Broughton, our consultants have deep industry knowledge across all the elements required for a PMTA. We guide you through and generate the required data, to ensure that FDA finds your applications strong and compelling.

 

Click to download

Next-Generation-Nicotine-Products-Service-Guide

Next Generation Nicotine Products Service Guide

We help companies of all sizes through the product lifecycle stages, from concept innovation, product realization, and regulatory submission to post marketing surveillance. 

Click to download

Strategic-Insights-to-reignite-PMTA-confidence

Strategic Insights to reignite PMTA confidence

Dr. Nveed Chaudhary Chief Scientific and Regulatory Officer,  Paul Hardman Managing Consultant Chemistry and Manufacturing Controls, and, Libby Clarke Managing Consultant Toxicology share their thoughts on how to reduce costs and protect timelines while continuing to innovate.

Click to download

Nicotine Industry Insight and Expert Opinion

Learn more about our activities and gain insight from our scientific and regulatory experts.

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The US Food and Drug Administration (FDA) has just announced an extension of its review of Premarket Tobacco Product Applications (PMTAs), as ....